Winrho Sdf Injection, Solution
NDC Package 49591-330-51

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Winrho Sdf (human rho(d) immune globulin) injection is winRho® SDF is a Rho(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rho(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rho(D)-negative patients. This formulation utilizes a injection, solution delivery system. Marketed by Kamada Ltd., this product is identified by NDC 49591-330 and is authorized under FDA application BLA103649.

Identification & Billing

NDC Package Code
49591-330-51
Package Description
1 VIAL, GLASS in 1 CARTON / 1.3 mL in 1 VIAL, GLASS (49591-330-11)
Product Code
49591-330
11-Digit Billing Format
49591033051
RxNorm Crosswalk
  • RxCUI: 1790374 - rho(D) immune globulin, human 2500 UNT in 2.2 ML Injection
  • RxCUI: 1790374 - 2.2 ML Rho(D) immune globulin, human 1136 UNT/ML Injection
  • RxCUI: 1790374 - rho(D) immune globulin, human 2500 UNT per 2.2 ML Injection
  • RxCUI: 1790379 - WinRho 2500 UNT in 2.2 ML Injection
  • RxCUI: 1790379 - 2.2 ML Rho(D) immune globulin, human 1136 UNT/ML Injection [WinRho]

Clinical Specifications

Proprietary Name
Winrho Sdf
Non-Proprietary Name
Human Rho(d) Immune Globulin
Substance Name
Human Rho(d) Immune Globulin
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
HUMAN RHO(D) IMMUNE GLOBULIN 1500 [iU]/1.3mL
Pharmacologic Class
Usage Information
WinRho® SDF is a Rho(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rho(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rho(D)-negative patients.

Regulatory & Marketing

Labeler Name
Kamada Ltd.
Product Type
Plasma Derivative
FDA Application #
BLA103649
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-01-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2792
Source: PDAC
INJECTION, RHO D IMMUNE GLOBULIN, INTRAVENOUS, HUMAN, SOLVENT DETERGENT, 100 IU
HCPCS Dosage 100 IU
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49591-330-51 identifies a specific commercial package of 1 vial, glass in 1 carton / 1.3 ml in 1 vial, glass (49591-330-11) of Winrho Sdf, a plasma derivative labeled by Kamada Ltd.. This injection, solution is formulated for intramuscular; intravenous use and contains human rho(d) immune globulin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kamada Ltd. on August 01, 2023. The current certification is valid through December 31, 2027.

How is this Kamada Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49591033051. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
49591-330-51
11-Digit CMS (5-4-2)
49591-0330-51

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.